Simply EZee

GUDID 00877972007371

GENICON, INC.

Tissue extraction bag
Primary Device ID00877972007371
NIH Device Record Key0edc5934-5f78-4ba3-8016-e6f886fa3b2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimply EZee
Version Model Number550-000-027
Company DUNS079805400
Company NameGENICON, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100877972007371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-29
Device Publish Date2018-10-29

On-Brand Devices [Simply EZee]

00877972007395550-000-026
00877972007371550-000-027
00877972007241550-000-020

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